antibacterial hand

ANTIBACTERIAL HAND - triclosan soap
Personal Care Products

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient:

Triclosan .2%

Purpose: Antibacterial

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Use: for hand washing to decrease bacteria on the skin.

Warnings:

For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush with water.

Stop use and ask a doctor if irritation and redness develops.

Directions: pump into hands, lather vigorously for at least 15 seconds, rinse and dry thoroughly.

Inactive ingredients: water (aqua), sodium lauryl polyoxyethylene ether sulfate, sodium lauryl sulfate, dodecyl dimethyl betaine, coconut oil acid diethanolamine, citric acid, disodium edta, sodium chloride, DMDM hydantoin, fragrance, red 40, D and C red 33

Personal Care antibacterial hand soap

berry

refill

15 fl. oz (443 ml)

ANTIBACTERIAL HAND
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:29500-9077
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (TRICLOSAN)	TRICLOSAN	.886 mL in 443 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
ETHER
SODIUM LAURYL SULFATE
BETAINE
DIETHANOLAMINE
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
SODIUM CHLORIDE
DMDM HYDANTOIN
D&C RED NO. 33

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:29500-9077-7	443 mL in 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/25/2011

Labeler - Personal Care Products (966155082)

Registrant - Personal Care Products (966155082)

Establishment
Name	Address	ID/FEI	Operations
Taizhou Ludao Co Ltd		679885595	manufacture

Revised: 10/2011 Personal Care Products